FDA Adverse Event
Malfunction
Summary report: N
PARAMOUNT (TM) VBR, 27 MM X 7MM X 0 DEGREES
MDR report key: 911524
·
Received September 12, 2007
Report
- Report Number
- 3005559743-2007-00002
- Event Type
- Malfunction
- Date Received
- September 12, 2007
- Date of Event
- August 13, 2007
- Report Date
- September 12, 2007
- Manufacturer
- INNOVATIVE SPINAL TECHNOLOGIES INC. (IST)
- Product Code
- MQP
- PMA / PMN Number
- K062759
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY UNDER EVALUATION.
Description of Event or Problem · 1
IN 2007, PT RECEIVED IST VBR (L4-S1). SURGEON PLACED ONE VBR (27MM X 14MM X 0 DEGREES) AT L4-L5 AND ANOTHER VBR (27MM X 7MM X 0 DEGREES) AT L5-S1. DURING PLACEMENT OF A SECOND VBR (27MM X 7 MM X 0 DEGREES) AT L5-S1, THE SURGEON STRUCK THE VBR INSERTER WITH THE MALLET AND THE VBR BROKE. THE SURGEON REMOVED THE VBR INSERTER, TO WHICH WAS ATTACHED A PORTION OF THE BROKEN VBR. THE SURGEON REMOVED THE REMAINDER OF THE BROKEN VBR. ANOTHER VBR (27MM X 7MM X 0 DEGREES) WAS IMPLANTED WITHOUT INCIDENT AND THE SURGERY WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARAMOUNT (TM) VBR, 27 MM X 7MM X 0 DEGREES | VERTEBRAL BODY REPLACEMENT DEVICE | MQP | INNOVATIVE SPINAL TECHNOLOGIES INC. (IST) | 19626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | DEPUY SPINE HEALOS (R) BONE GRAFT REPLACEMENT| IST PARAMOUNT (TM) VBR |